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FDA Approves First Human Trials Of Zika Vaccine
The first clinical tests in people of a new vaccine to combat the Zika virus will begin in the next several weeks, a Philadelphia area biotech company announced Monday.
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Inovio’s Phase I study will test GLS-5700 in 40 healthy subjects using Inovio’s DNA delivery system Cellectra. The US National Institute of Diseases Allergy and Infectious Diseases (NIAID) is also designing its own zika vaccine, whose human trials will begin in September as recently announced by its director, Anthony Fauci.This clinical trial will involve 40 patients. These small trials are created to determine whether a product is safe to administer to people and to determine the effective dosage.
The vaccine has been tested in various animal models, and has resulted in what Inovio says have been a robust response from T cells antibodies.
Inovio is developing the DNA-based vaccine – using DNA sequences of the Zika virus – in collaboration with the Wistar Institute in University City. The human testing is expected to start in the next few weeks.
Since the Zika outbreak, drug companies have been racing to develop a Zika virus vaccine.
“It is an honor for our company to help usher this Zika vaccine through the clinical and regulatory process”. How will this Zika vaccine work?That lead might be precarious, however. Recently, the World Health Organization has announced that large-scale testing for any of the Zika vaccines in development will unlikely begin for at least 18 months.
The mosquito-driven Zika virus is associated with severe birth defects, like microcephaly, which is characterized by a significantly small head and brain developmental problems.
However, reports indicate that the Zika vaccine is still in the very early stage of development. The virus can cause devastating birth defects.
The first Zika diagnosis on the United States mainland was made in Texas in February 2016. Kim added that they will report the results of the Phase 1 clinical trials later this year.
“As of May 2016, 58 countries and territories reported continuing mosquito-borne transmission of the Zika virus”, said Kim.
Inovio Pharmaceuticals’ Zika vaccine will be the 14th drug the company has in testing, but its CEO insisted Tuesday the company is not spread too thin and is ready to take on its larger rivals.
No vaccine or therapy now exists for Zika, a mosquito-borne illness that can cause fevers and rashes in infected people. Well, it sounds like avoiding mosquito bites at all costs is the best plan, especially since Zika isn’t the only thing to worry about.
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Zika has become epidemic in Latin America and the Caribbean since last fall.